FDA Food and Drug Administration - Index to Drug-Specific Information - This Index does not include all FDA approved drugs. It only includes drugs that have been the subject of a Healthcare Professional Information sheet, an Early Communication About an Ongoing Safety Review, or other important information. Please use Drugs@FDA to search for information on a drug not found in the Index.
The Medical Product Safety Network (MedSun) improves FDA's understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns. The MedSun Web page is a newsletter-based website which provides monthly updates about timely medical device issues that may impact patient safety. This website also provides public access to de-identified reports 2 sent into the MedSun program, in addition to important safety information to MedSun participants and to the national clinical community about reported problems.
FDA is an agency within the Department of Health and Human Services1 and consists of centers and offices responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.
CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.
MedWatch - FDA Safety Information and Adverse Event Report Program - MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts contain actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.
The Center conducts research through the dedicated efforts of staff in seven divisions. The NCTR Research Divisions are committed to the study of biochemical and molecular markers of cancer, nutritional modulation of risk and toxicity, developmental toxicity, neurotoxicity, quantitative risk assessment, transgenics, applied and environmental microbiology, and solid-state toxicity
FDA.gov - Device Approvals and Clearances - STAN S31 Fetal Heart Monitor. STAN® S31 Fetal Heart Monitor is new type of fetal monitor that uses the fetal electrocardiogram (ECG) obtained through a fetal scalp electrode during labor to help the doctor or midwife decide whether to allow the mother to continue to labor or to intervene and deliver the baby.
TheraSuit is the most recent and sophisticated design yet, but does not require lengthy training or special skills. TheraSuit was created to be used by therapists and parents alike, both during therapy time and out of the clinical setting. TheraSuit is the only one of these kind of devices in United States registered with FDA and meeting all requirements and regulations. Currently there is more than 161 clinics around world: North America, South America, Europe, Asia and Middle East successfully using TheraSuit. There is more than 2,000 trained therapists using TheraSuit Method (Suit Therapy) in their clinics and hundreds of trained parents using TheraSuit with their children at home on the daily basis.
Study comparing diazepam, a drug that is labeled by the FDA for this indication, with lorazepam. The study will show whether one drug is more effective and safer than the other.
Provides links to information on Drug and Device Information, Device Approvals and Safety information as well as links to other information government and private sector web sites
PDR.net - The Physician's Desk Reference web site. Provides full FDA approved product labeling, drug interaction checker, PDR eBooks, patient information and more